Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System

NCT05208138 | Terminated Phase 2 DMC

• 1 other identifier: STD0005853
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric Surgery; Robotic Surgery

Outcome Measures

Primary Outcomes (10)

• Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery

  Number of patients with intraoperative bleeding

  During operation, up to 2 hours

• Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery

  Number of patients with intraoperative organ lesion

  During operation, up to 2 hours

• Rate of procedure interruption using the Senhance Surgical System in bariatric surgery

  Number of patients with procedure interruption

  During operation, up to 2 hours

• Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery

  Number of patients with postoperative bleeding

  up to 30 days postoperatively

• Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery

  Number of patients with anastomotic or staple line leakage

  up to 30 days postoperatively

• Rate of surgical site infection using the Senhance Surgical System in bariatric surgery

  Number of patients with surgical site infection (deep or superficial)

  up to 30 days postoperatively

• Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery

  Number of patients with a cardiovascular complication

  up to 30 days postoperatively

• Rate of respiratory complication using theSenhance Surgical System in bariatric surgery

  Number of patients with a respiratory complication

  up to 30 days postoperatively

• Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery

  Number of patients with a thromboembolic complication

  up to 30 days postoperatively

• Rate of renal complication using the Senhance Surgical System in bariatric surgery

  Number of patients with a renal complication

  up to 30 days postoperatively

Secondary Outcomes (5)

• Feasibility of the Senhance Surgical System in bariatric surgery

  During operation, up to 2 hours

• Feasibility of the Senhance Surgical System in bariatric surgery

  During operation, up to 2 hours

• Feasibility of the Senhance Surgical System in bariatric surgery

  During operation, up to 2 hours

• Feasibility of the Senhance Surgical System in bariatric surgery

  at hospital discharge, up to 30 days

• Feasibility of the Senhance Surgical System in bariatric surgery

  up to 30 days postoperatively

Study Arms (1)

Intervention

EXPERIMENTAL

Bariatric operation with the Senhance surgical system

Device: Senhance Surgical System from Asensus

Interventions

Senhance Surgical System from Asensus DEVICE

Bariatric operation with the Senhance Surgical System

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• ≥ 18 years old
• Capable of judgment
• Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System

You may not qualify if:

• \< 18 years of age
• Participants incapable of judgment or participants under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• No informed consent signed
• Women who are pregnant
• High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure)
• Contra-indication for laparoscopic surgery
• Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

Location

Study Officials

• Philipp C Nett, MD

  Inselspital Universitätsspital Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single arm, two-stage phase II study

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 26, 2022
• Study Start: January 20, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)